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BLOXIVERZ

NDA

NEOSTIGMINE METHYLSULFATE | N204078 | EXELA PHARMA SCIENCES LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

PATHEON AUSTRIA GMBH AND CO KGNEOSTIGMINE METHYLSULFATE

DMF 247602011

EMCURE PHARMACEUTICALS LTDNEOSTIGMINE METHYLSULFATE USP

DMF 283972014

MSN LABORATORIES PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP [ROUTE CODE "NS"]

DMF 291972015

HARMAN FINOCHEM LTDNEOSTIGMINE METHYLSULFATE USP

DMF 301362015

INDOCO REMEDIES LTDNEOSTIGMINE METHYLSULFATE USP

DMF 310032016

ENALTEC LABS PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP

DMF 313872018

GLAND PHARMA LTDNEOSTIGMINE METHYLSULFATE

DMF 321532017

APITORIA PHARMA PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP

DMF 331302018

HUBEI HAOSUN PHARMACEUTICAL CO LTDNEOSTIGMINE METHYLSULFATE

DMF 380872023

HOFFMANN LA ROCHE INCInactiveNEOSTIGMINE METHYLSULFATE

DMF 69411987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 15, 2023	SUPPL -14	View Letter (PDF)
Jan 21, 2021	SUPPL -10	View Letter (PDF)
Oct 21, 2015	SUPPL -7	View Letter (PDF)
Dec 12, 2014	SUPPL -4	View Letter (PDF)
Jun 4, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG/10ML (0.5MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 31, 2013

No patent or exclusivity listings for this strength.

#002 — 10MG/10ML (1MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 31, 2013

#003 — 5MG/5ML (1MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Oct 27, 2023